(829 days)
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No
The summary does not mention AI, ML, or related terms, and the description of the device and performance studies focuses on sEMG signal analysis and threshold-based alerting, which are not inherently AI/ML techniques.
No.
The primary purpose of the device is for monitoring and alerting caregivers to potential generalized tonic-clonic seizures, not for direct treatment or intervention of the condition itself.
Yes
The device analyzes sEMG signals associated with generalized tonic-clonic seizures, records and stores sEMG data for review by a healthcare professional, and alerts caregivers to potential GTC seizures, all of which are diagnostic functions.
No
The device description explicitly states it has two main components: the sEMG monitor (hardware worn on the arm) and the base station (hardware for alerts). This indicates it is not a software-only device.
Based on the provided information, the Brain Sentinel Monitoring and Alerting System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a person's health.
- Brain Sentinel's Function: The Brain Sentinel system analyzes surface electromyograph (sEMG) signals directly from the patient's muscle (belly of the biceps). It does not process or analyze specimens taken from the body.
- Intended Use: The intended use is for monitoring and alerting based on physiological signals from the body, not for analyzing biological samples.
Therefore, the Brain Sentinel Monitoring and Alerting System falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The device is to be used on the belly of the biceps muscle to analyze surface electromyographs (sEMG) signals that may be associated with generalized tonic (GTC) seizures and to provide an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.
Product codes
POS
Device Description
The Brain Sentinel Monitoring and Alerting System is a sEMG-based system for identifying sEMG activity that may be associated with generalized tonic-clonic seizures (GTCS). The device has two main components: the sEMG monitor and the base station. The sEMG monitor is worn on the patient's upper arm and monitors EMG activity in the arm via cutaneous electrodes connected to the sEMG monitor. Upon identification of sEMG activity, the monitor communicates wirelessly to the base station, which alerts a healthcare provider or caregiver in one or more ways (e.g., audible alarm, text message, e-mail, etc.).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
belly of the biceps muscle, upper arm
Indicated Patient Age Range
Adults
Intended User / Care Setting
Caregivers, trained healthcare professional, home or healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
A prospective, multicenter, non-randomized study was carried out at eleven (11) National Association of Epilepsy Centers (NAEC) Level IV Epilepsy Centers to evaluate the operating characteristic of the Brain Sentinel Monitoring and Alerting System. During the trial the subject device was connected, unilaterally, to the upper extremity at the belly of the biceps brachii muscles while subjects were receiving routine clinical care and monitoring in the Epilepsy Monitoring Unit (EMU). Subjects, caregivers, and the independent epileptologists were blinded to the alarm status of the System.
Identification of GTC seizures was performed by three independent neurologists who reviewed the vEEG records of each subject's EMU stay to determine if and when generalized tonic clonic (GTC) seizures occurred. A majority rules approach was taken to identify GTC Seizures that consisted of a tonic phase followed immediately by a clonic phase. The time of bilateral, appendicular, tonic extension, reported by each reviewer, was averaged for comparison to the time of alert from the device.
For each seizure identified, agreement between the subject device and the independent epileptologists was documented when the device was able to identify sEMG signals that may be associated with a GTC seizure in less than 30 seconds of the time of bilateral, appendicular, tonic extension identified by the independent epileptologists. The subject device was considered to report a false alarm when it identified sEMG data as an event, and the independent epileptologists did not identify a GTC seizure in less than 30 seconds of that time on vEEG.
Testing was performed on two cohorts:
Intent to Monitor (ITM cohort): Includes all subjects (n=199) in the study whether or not any sEMG data was recorded and whether or not the device was properly placed.
Properly Placed (PP cohort): Includes subjects (n=149) with sEMG data continuously recorded while a device was properly placed for at least 1 placement (a placement was typically a day).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Prospective, multicenter, non-randomized study.
Sample Size:
- Intent to Monitor (ITM) Cohort: N=199 unique subjects.
- Properly Placed (PP) Cohort: N=149 unique subjects.
- Adult subjects within ITM: N=139.
- Adult subjects within PP: N=106.
Standalone Performance: Not a standalone monitoring device.
Key Results:
ITM Cohort (Adults, N=139) at default sensitivity setting of 135:
- PPA (1st and 2nd seizure): 82% (95% CI: 71%, 1.0)
- PPA (1st seizure only): 85% (95% CI: 68%, 1.0)
- Time to Alarm (avg, SEM, range, median): Average: 5.49, SEM: 2.36, Range: -30.82 - 25.06, Median: 6.67
- False positives per 8 hours: 0.72 (95% CI: 0.49, 1.18)
- Mean false alarms per 8 hours averaged across subjects: 0.77 (95% CI: 0.39, 1.16)
PP Cohort (Adults, N=106) at default sensitivity setting of 135:
- PPA (1st and 2nd seizure): 100% (95% CI: 92%, 1.0)
- PPA (1st seizure only): 100% (95% CI: 84%, 1.0)
- Time to Alarm (avg, SEM, range, median): Average: 5.34, SEM: 2.86, Range: -30.82 - 25.06, Median: 6.67
- False positives per 8 hours: 0.51 (95% CI: 0.38, 0.76)
- Mean false alarms per 8 hours averaged across subjects: 0.53 (95% CI: 0.36, 0.69)
- The lower bound on PPA of the 95% CI for the PP analysis was 92% for adults for the first and second seizures.
- ITM analysis for the adult patients group had a lower bound 95% CI of 71% for the first and second seizures.
Safety Results:
- 28% (55/199) of subjects reported a device related adverse event.
- All events were mild to moderate, no serious adverse events.
- Most common adverse event: mild skin irritation (17%, 34/199), moderate skin irritation (6%, 11/199).
- Skin tears: 3% (5 individuals).
- All skin irritation resolved without treatment or sequelae.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Percent Agreement (PPA), False Alarm Rate (FAR).
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 882.1580 Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.
(a)
Identification. A non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system is a noninvasive prescription device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information:
(i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.
(ii) Software, including any proprietary algorithm(s) used by the device to achieve its intended use, must be described in detail in the Software Requirements Specification (SRS) and Software Design Specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) The device must be designed and tested for electrical, thermal, and mechanical safety and electromagnetic compatibility (EMC).
(4) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for monitoring for seizure-related activity in the intended population and for the intended use setting. Performance measurements must include positive percent agreement and false alarm rate.
(5) Training must be provided for intended users that includes information regarding the proper use of the device and factors that may affect the collection of the physiologic data.
(6) The labeling must include health care professional labeling and patient-caregiver labeling. The health care professional and the patient-caregiver labeling must include the following information:
(i) A detailed summary of the clinical performance testing, including any adverse events and complications.
(ii) Any instructions technicians and clinicians should convey to patients and caregivers regarding the proper use of the device and factors that may affect the collection of the physiologic data.
(iii) Instructions to technicians and clinicians regarding how to set the device threshold to achieve the intended performance of the device.
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DE NOVO CLASSIFICATION REQUEST FOR
Brain Sentinel® Monitoring and Alerting System
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Non-EEG physiological signal based seizure monitoring system. The nonelectroencephalogram (non-EEG) physiological signal based seizure monitoring system is a non-invasive prescription device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure.
NEW REGULATION NUMBER: 21 CFR 882.1580
CLASSIFICATION: II
PRODUCT CODE: POS
BACKGROUND
DEVICE NAME: Brain Sentinel Monitoring and Alerting System
SUBMISSION NUMBER: DEN140033
DATE OF DE NOVO: November 10, 2014
CONTACT: LGCH, Inc. d/b/a Brain Sentinel 115 N Loop, 1604 E., Suite 1203 San Antonio, TX 78232-1399
INDICATIONS FOR USE
The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The device is to be used on the belly of the biceps muscle to analyze surface electromyographs (sEMG) signals that may be associated with generalized tonic (GTC) seizures and to provide an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.
LIMITATIONS
For prescription use only.
The device is not a GTC seizure detection device and should not be used to guide medical therapy decisions.
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The safety and effectiveness of the Brain Sentinel® Monitoring and Alerting System has not been established in monitoring sEMG signals that may be associated with seizures other than the GTCS.
The safety and effectiveness of the Brain Sentinel® Monitoring and Alerting System has not been established in pediatric populations.
The device is not intended to be used as a stand-alone monitoring device.
The device is not intended to be used during physical activity.
This device does not predict seizure onset.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The Brain Sentinel Monitoring and Alerting System is a sEMG-based system for identifying sEMG activity that may be associated with generalized tonic-clonic seizures (GTCS). The device has two main components: the sEMG monitor and the base station. The sEMG monitor is worn on the patient's upper arm and monitors EMG activity in the arm via cutaneous electrodes connected to the sEMG monitor. Upon identification of sEMG activity, the monitor communicates wirelessly to the base station, which alerts a healthcare provider or caregiver in one or more ways (e.g., audible alarm, text message, e-mail, etc.).
Description of the sEMG Monitor
Image /page/1/Picture/9 description: The image contains three different views of a detection device. The first image, labeled (a) Front View, shows the front of the device, which has two buttons and a logo. The second image, labeled (b) Back View, shows the back of the device, which has a saddle latch, a detection device rear enclosure, a detection device front enclosure, a saddle, and an electrode patch. The third image, labeled (c) Harness, shows the device attached to a harness.
Figure 1 - The sEMG Monitor (a) the front View, (b) the back view, and (c) the device harness
The sEMG Monitor (Figure 1) is attached to the sEMG electrodes placed on a person's upper arm over the belly of the biceps muscle. The Harness (c) is used to secure the Monitor to the patient's arm in place so that the Monitor does not get separated from the electrodes.
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Description of the Base Station
Image /page/2/Picture/1 description: The image shows a black Acer laptop. The screen displays a dashboard with various graphs and data points, with the time 16:08:24 visible in the upper left corner. The laptop is open, revealing a full keyboard and touchpad. The background is black, which helps to highlight the laptop.
Figure 2 - Base Station Computer
The base station (Figure 2) is a laptop computer with a touch screen for ease of operation. The laptop runs on Windows 7 operating system and is provided to the end user with all the necessary software installed.
The output of the Brain Sentinel Monitoring and Alerting System is an alert to indicate that sEMG activity that may be associated with a GTC seizure is occurring. A modifiable threshold (a numerical value ranging from 135-215) is available for the caregiver to adjust the sensitivity or the false alarm rate of the system. There is an inverse relationship between the threshold number and the sensitivity of the algorithm. The higher the number, the less sensitive the device is; and lower the number, the greater its sensitivity.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The sEMG Monitor housing, Saddle, and Arm Strap come in contact with the patients and are classified as intact skin-contacting components of the Brain Sentinel® Monitoring and Alerting System. These patient-contacting components were tested for biocompatibility in accordance with ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. All biocompatibility studies were conducted in compliance with Good Laboratory Practices (GLP). 21 CFR Part 58. The biocompatibility test data are summarized in Table 1 below. The ECG/sEMG electrodes used with the Brain Sentinel® Monitoring and Alerting System are off-the-shelf electrodes cleared in K842514 and K864690.
| Biological
Effect
(Applicable
| Standard) | Test Method | Evaluation Criteria | Results |
|---|---|---|---|
| Arm Strap: | |||
| Cytotoxicity | |||
| (ISO 10993-5) | ISO Agarose Overlay Test | The test article meets the requirements of the test | |
| if reactivity grade is ≤ 2 (mild reactivity). | Non-Cytotoxic |
| Table 1 - Biocompatibility Test Data on sEMG Monitor Housing, Saddle, and Arm Strap | ||
|---|---|---|
| -- | -- | ------------------------------------------------------------------------------------- |
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| Biological
Effect
(Applicable
| Standard) | Test Method | Evaluation Criteria | Results |
|---|---|---|---|
| Sensitization | |||
| (ISO 10993-10) | ISO Closed Patch Sensitization | ||
| Test in Guinea Pigs | Grades of ≥ 1 in the test group generally indicate | ||
| sensitization provided grades of |